Global Clinical Development Director — Trials & Strategy

PTC Therapeutics, Inc; Virginia (MN); Presencial; USD 267 000 - 336 000; Tempo integral

Resumo da oferta

PTC Therapeutics, Inc. is seeking a Director of Clinical Development to oversee all phases of drug development, from protocol design to data analysis, ensuring alignment with GCP and regulatory standards.

The role involves cross-functional collaboration, external stakeholder engagement, and leadership of clinical programs. Travel up to 25% is expected as part of regulatory meetings and partnerships.

Qualificações

• MD degree with clinical drug development experience and regulatory exposure.
• Experience managing global clinical programs and regulatory submissions.
• In-depth knowledge of GCP, regulatory processes and drug development milestones.
• Ability to influence without direct authority and communicate effectively.

Responsabilidades

• Contributes to and approves study protocols, CSRs, IBs and other essential documents.
• Plans investigator meetings and oversees study timelines and enrollment data.
• Interprets clinical data and prepares regulatory and publication materials.
• Represents the clinical study team in cross-functional meetings.

Conhecimentos

MD degree

Clinical drug development

Global program management

Regulatory submissions

Microsoft Office

Verbal & written communication

Independent & collaborative work

Analytical thinking

Time management

Travel willingness

Formação académica

MD degree

Ferramentas

Microsoft Office

Descrição da oferta de emprego

PTC Therapeutics, Inc. is seeking a Director of Clinical Development to oversee all phases of drug development, from protocol design to data analysis, ensuring alignment with GCP and regulatory standards.

The role involves cross-functional collaboration, external stakeholder engagement, and leadership of clinical programs. Travel up to 25% is expected as part of regulatory meetings and partnerships.